FDA rule on morning-after pill draws strong reaction

By this summer, a 15-year-old girl will be able to walk into a drugstore, scan the shelves and purchase the morning-after pill without a prescription, a controversial national decision at the intersection of women’s reproductive rights, parenting, sciences and the role and reach of government.

On Tuesday the Food and Drug Administration ordered retailers to offer the emergency contraceptive Plan B One-Step as an over-the-counter option — the latest ruling in a long battle, both legal and social, about the rights of women to have access to the drug. Before now, the pill, which is used after sexual intercourse to help prevent pregnancy, was available to women ages 17 and older without a prescription, but the medication was kept behind drugstore counters.

The FDA’s decision came weeks after a federal judge ordered that over-the-counter emergency contraception be made available to females of any age — a ruling the Obama administration is appealing.

Even with many practical questions still unanswered and the specter of more court rulings looming, reaction has been passionate on both sides of the issue.

“This is a policy issue that basically represents people’s core beliefs,’’ says Nicole Ruggiano, an assistant professor of social work at Florida International University’s Robert Stempel College of Public Health and Social Work. “This is about people’s beliefs about premarital sex, parenting, religion, right to life and those kinds of issues.’’

President Obama, visiting Mexico, said Thursday he was “comfortable” with the FDA’s decision.

For some, this is a victory long in the making, empowering young sexually active women. Opponents, including those with strong religious beliefs, contend the decision is wrong, that 15-year-olds are too young to make such a sensitive decision, particularly without the consent of parents. They are also concerned about the elimination of safeguards provided by prescriptions that require a healthcare provider’s input.

And still for others, the decision is simply reflection of the realities of teenage sexual choices.

“At 15, a child should not be having sex, but let’s face it, they do,’’ said Barry Stephenson, a Lauderhill father of four. “I would agree with it in certain cases but definitely don’t condone it in general because I think they are too young to make that kind of decision.’’

In April, New York U.S. District Judge Edward R. Korman ordered the FDA to make the emergency contraception available to females of any age, without a prescription. As part of the ruling in a federal lawsuit, Korman took the Obama administration to task for politicizing science by restricting access to the drug two years ago.

Unrelated to Korman’s ruling, the FDA announced approval this week of manufacturer Teva’s application to offer Plan B without a prescription for females 15 or older — but the product will not be available in over-the-counter form until the summer, after inventory and packaging issues are worked out. Teens will be required to show proof of age.

On Wednesday, the Justice Department filed a notice it will appeal Judge Korman’s ruling, which goes into affect on May 10. The Obama administration has asked the judge to delay his ruling until the appeal can be heard. The judge will hear oral arguments on Tuesday.

“We are outraged by the government continuing to play politics with a safe and effective form of birth control that should have been over-the-counter 10 years ago,’’ said Gainesville resident Candi Churchill, part of the Gainesville chapter of the National Women’s Liberation and one of the plaintiffs in the federal lawsuit. “The Bush and Obama administrations have interfered with the FDA on a level never seen before. They are affecting our lives and ability to decide if and when we get pregnant. We believe that if a female is old enough to get pregnant, she is old enough to decide if she doesn’t want to be.”

Along with women’s health groups, much of the medical world has supported the use of emergency contraception as safe.

“It is a safe and effective product in which the benefits outweigh the risks. But it is intended as a back-up method, not a primary method of birth control,’’ said Dr. Karen Y. Tang, assistant professor of Clinical Obstetrics and Gynecology at the University of Miami Miller School of Medicine. “This is for situation in which there is a malfunction of a birth-control method or an accident.’’

Still, there are those who question why the lack of regulation.

“The court and the FDA are acting irresponsibly by making this powerful drug available without a prescription to minor children. The court’s action undermines parents’ ability to protect their daughters from the adverse effects of the drug itself,’’ said Barbara Groeber, education coordinator of the Archdiocese of Miami’s Respect Life Ministry.

Coconut Grove resident Rebecca Chancy began following the case as a topic in the presidential election. She views the decision as a fair compromise on the lightning-rod issue of access to emergency contraception.

“I am amazed that anyone would be more inclined to have a 15-year-old raise a child than take a medication, which should be sold over the counter since there is no medical evidence that taking the pill hurts the patient,’’ said Chancy, 30, who works in accounting. “It’s a moral argument that belongs in a church, not a pharmacy.’’

Christi Hayes, responding to an inquiry on the Miami Herald’s Facebook account, supports the FDA’s decision also.

“Young girls are the least prepared for pregnancy. Emergency contraception — if taken in time — prevents pregnancies. Why limit its availability?” she wrote in an email. “Emergency contraception doesn’t lead to kids having sex any more than Tylenol leads college students to get drunk. Restricting this pill does nothing to protect young women.’’

But for Father Alfred Cioffi, an Archdiocese of Miami priest for 28 years, the contraception “promotes sexual intimacy.’’

“It pushes sex more and more into the realm of casual entertainment,’’ said Cioffi, who also teaches biology and bioethics and St. Thomas University.

Shirley Mantilla, 23, a Miami mother of four, can’t imagine her daughter having access to the morning-after pill.

“I got pregnant at 14 and gave birth at 15 and I have to tell you I am very opposed to giving the girls access. There are options if you have an unwanted pregnancy, like adoption,’’ she said. “And I would feel like I failed as a parent if she went behind my back and did this. I would rather see her come to us and I would love her and my grandchild.’’

A previous version of this article had an incorrect title for Candi Churchill, part of the Gainesville chapter of the National Women’s Liberation and one of the plaintiffs in the federal lawsuit.